Proposed standards for the design and conduct of a national clinical audit or quality improvement study.

PURPOSE: The purposes were to find and synthesize available literature on explicit or implicit standards for the design and conduct of a national activity that involves measuring and facilitating improvement of the quality of patient care, such as a national clinical audit or a quality improvement (QI) study, and to develop proposed standards for the design and conduct of the national activity. DATA SOURCES, SELECTION AND ANALYSIS: The literature was searched to identify key aspects of good practice in the conduct of national or international clinical audits, QI studies, performance or quality indicator measurements or equivalent national initiatives that have the purpose of driving improvement in the quality of care provided in a healthcare system. Key aspects of good practice in design or operation of these activities were abstracted from the literature, and organized logically into standard statements according to the stages in the design or conduct of such an activity.
RESULTS: Thirty standards for the design and conduct of a national clinical audit or QI study were derived from the published literature. The standards are on structural, process and outcome aspects of any national activity that involves measuring and improving healthcare services. Most of the standards focus on measurement processes.
CONCLUSION: It is hoped that these proposed standards for a national clinical audit or QI study will facilitate debate on how to assure the quality of these national activities. Activities that meet accepted standards may be more effective in influencing participating sites to achieve improvements in the quality of care.